UPDATE ON NEW REGULATORY FRAMEWORK FOR MEDICAL DEVICES

Preamble: The medical technology industry contributes greatly  to Europe’s economy. With a total market of roughly €100 billion, equivalent to around one third of the global medical technology market, this sector as an industry provides a substantial potential to Europe’s economy. It provides more than 575,000 high-quality jobs, across almost 25,000 medical technology companies in Europe. At the same time, the industry allows millions of citizens to be more healthy and remain productive, contributing to economic growth The medical technology industry in Europe is also an engine of innovation. In 2012, more than 10,000 patent applications were filed with the European Patent Office (EPO) in the field of medical technology. This is equivalent to 7% of the total number of applications, and comprises more patent applications than any other technical field. The industry is characterised by a very high proportion of Small and Medium-sized Enterprises (SMEs). In fact around 95% of all medical technology companies in Europe have less than 250 employees. The speed and flexibility of these SMEs, working collaboratively with healthcare professionals and academia, stimulates the rapid development of improved or breakthrough products addressing specific patient needs. Innovation cycles are on a par with those in information technology; a new introduction is usually replaced by an improved version every 18-24 months. This continuous commitment to innovation, and the substantial investment that underpins it, is crucial to Europe’s ambitions to become a smart, sustainable and inclusive economy fuelled by an active and healthy population

The task of harmonizing requirements and regulating medical devices is handled by the European Commission in close cooperation with Member State’s Health Authorities. The purpose of the EU harmonization effort is to merge the differing national requirements into one law which will be applied throughout the European Union. Legislation adopted through this process covers implantable, non-implantable and in vitro diagnostics medical devices in three separate directives that provide manufacturers the basics to certify their compliance with EU-wide safety requirements.

Adopted Legislation has focused on:

1. Active implantable medical devices (AIMD), such as heart pacemakers or defibrillators defined as “any active medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure.
2. Medical devices  broadly defined as “any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings” for several purposes such as diagnosis, treatment, alleviation of disease and more.
3. In vitro medical devices (IVD) defined as “reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system, whether used alone or in combination intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body solely or principally for the purpose of providing information.” It covers items such as pregnancy test kits and blood analysis machines.

New Regulatory Framework

Currently, the regulatory framework is being revised with the rollout of the new regulation planned for 2016. Many groups and experts in Europe, including doctors, patients and industry, agree that the current European system needs to be improved to cope with new medical technologies and innovations. However, a radical overhaul won’t guarantee more safety and risks introducing unnecessary delays.

On 26 September 2012, the European Commission  initiated a Proposal for a new Medical Devices Regulations (MDR) and In Vitro Diagnostic Devices Regulations (IVDR) to replace the existing three medical devices directives. The Proposal focuses on extending the scope, possibly creating a Medical Device Committee within the European Medicines Agency (EMEA), improving the vigilance and post-market surveillance system, updating the regulatory framework after the revision of the New Approach and further aligning the EU system with the international regulatory principles of the Global Harmonization Task Force for medical devices (GHTF).

Experts point out, however, that the MDR proposal is too much focused on regulating ‘traditional’ medical devices and not well enough equipped to deal with new technological developments. While the MDR and IVDR proposals address ‘devices as service’ provided via the internet succinctly, software related issues such as compatibility, interfacing standards and security are not addressed in any detail. Rapid developments in 3D printing make it possible today to  print custom-made devices such as orthopaedic implants and artificial veins.

Crucial elements of the proposed regulations are still subject to political debate. A trialogue between the Commission, Parliament and Council is not expected before early 2015. With the reshuffling of the political landscape following the European elections, there are a lot of insecurities about the legislative projects of MDR and IVDR post-elections.

Nevertheless, it is AALEP’s  view that all companies should plan and prepare for the new rules because EU law does not allow grandfathering of devices, so every device will have to have been certified under the new rules  in the transitional time frames provided (3 year transition). That means that companies should:

1. Invest in qualified persons to function as person responsible for regulatory compliance or appoint qualified persons already in their organization who may need additional training for the tasks required of that person.
2. Plan and budget for the changes. This will not only involve internal analysis of technical documentation, quality system, Standard Operating Procedures (SOPs) and amendment of contracts, but also making a gap analysis and drawing up a transition plan for all devices on the market. Companies will need to take into account that notified body slots to conformity assessment will be scarce during the transitional period. Not having obtained a certificate under the new rules before the end of the transitional period will mean taking the product off the market until a certificate is obtained.
3. Identify what (additional clinical date will be required for their medical device or IVD and start to generate that data. Waiting until the transitional period starts may well put the manufacturer in a squeeze if the clinical evidence is not available in time for conformity assessment by the notified body, and they may need to take the device off the market until a new certificate has been granted.

The future of 25,000 companies across Europe is at stake.

Please contact AALEP for further information.